NCT07223450

A Study on Oral and Intranasal Forms of Oxycodone in Healthy Volunteers Using Pharmacokinetic Modeling

Physiologically Based Pharmacokinetic Modelling of Oral and Intranasal Formulations of Oxycodone in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Parc de Salut Mar · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-dose, 2-period, 2-sequence, fasting, open label, crossover randomized design, comparing the pharmacokinetics (PK) and pharmacodynamics (PD) of intranasal and oral oxycodone solutions. The aim will be to characterize the PK and PD of two formulations of oxycodone (intranasal and oral) in healthy subjects, which will be used to verify/validate nasal-CNS-PBPK (Physiologically Based Pharmacokinetic) model predictions following intranasal dosing. A total of 8 healthy male/female subjects will be randomly assigned to one of two sequences in the crossover study. All subjects will receive the same dosage of oxycodone intranasal or oral and the sequence will be determined following randomization.

Conditions

• Physiologically Based Pharmacokinetic
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Oxycodone IN	0.1 mg/kg intravenously oxycodone solution administered intranasally
DRUG	oxycodone	oral solution 0.1 mg/kg

Timeline

• Start date: 2025-06-12
• Primary completion: 2025-10-07
• Completion: 2025-10-07
• First posted: 2025-10-31
• Last updated: 2025-10-31

Locations

1 site across 1 country: Spain